Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Catalent Says It's Not Our Facility; It Belongs To Novo Nordisk

The FDA informed us again in April that the Bloomington, Indiana, facilities owned by Catalent until sold to Novo Nordisk in December 2024, have not solved quality issues. This adds to an FDA inspection/poor response and remediation history years long in the making. How is it we are witnessing this at a U.S. facility run by a name-brand CDMO and then Big Pharma? Catalent, for its part, wants to stop "inaccuracies in media coverage." Here's analysis from an experienced pharma professional and our own Chief Editor Louis Garguilo.

GUEST COLUMNISTS

July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
The Unspoken Truth About Cell Therapy Product Understanding
Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.
Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.
The Complex Anatomy Of An ADC Tech Transfer
Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

PHARMA OUTSOURCING WHITE PAPERS

Achieve Higher Targeted Concentrations
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

FIH: Reach Milestones Sooner With A Technology-Driven Approach
Accelerate your path to IND and FiH with AI-driven design, advanced cell line engineering, and intensified processes delivering high titers in 9–14 months.
(Cross-) Contamination Control Through Effective Equipment Cleaning
Discover science-driven cleaning strategies that reduce cross-contamination, enable safe multiproduct manufacturing, and support faster, flexible GMP changeovers.
Innovation In Filtration
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
Building Late-Stage Efficiency Into Biologics Development
Building late-stage efficiency early in biologics development prevents scale-up delays. Flexible platforms and risk-based validation streamline technology transfer and lower production costs.
Challenges And Solution In The Poly (A) Control For Plasmid And mRNA
Poly(A) tail integrity is critical for mRNA stability and translation. Advanced strategies optimize plasmid design, transcription, and purification to ensure consistent poly(A) control for therapeutic success.